Cleared Traditional

K896967 - HTS 820 CARDIAC MONITOR

K896967 is the FDA 510(k) clearance for HTS 820 CARDIAC MONITOR by Life Sensing Instrument Company, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K896967 · Life Sensing Instrument Company, Inc. · Cardiovascular device
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Mar 1990
Decision
91d
Days
Class 2
Risk

K896967 is an FDA 510(k) clearance for the HTS 820 CARDIAC MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Life Sensing Instrument Company, Inc. (Tullahoma, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Sensing Instrument Company, Inc. devices

Submission Details

510(k) Number K896967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 19, 1990
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 229
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K896967.
TRAM PATIENT MONITOR
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MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
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K897063 · Fukuda Denshi USA, Inc. · Feb 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · Fukuda Denshi USA, Inc. · Jan 1990